The EU Medical Device Regulation (MDR) will replace the current EU Medical Device Directive (MDD) on May 26, 2021. Companies whose products are approved for sale in Europe must decide if they want to go through the process to bring those products into compliance with EU MDR.

All of this would have been time-consuming and costly, but straightforward if it weren’t for a couple of factors: the COVID-19 pandemic and the more stringent requirements on the companies that perform the audits for each device, also known as notified bodies.

Notified body fallout
Each company seeking designation as a notified body must meet certain requirements. Because the MDR is more complex and more expensive to carry out, many smaller notified bodies have decided to drop out of the process, according to Gary Slack, SVP of medical devices at BSI, the EU’s largest notified body.

As of October 21, 2020, the number of notified bodies had dropped from 80 to 17, with 48 additional companies seeking notified body designation. (The 17 figure includes two listings for BSI, one for its UK headquarters and a second for its office in Amsterdam. Due to Brexit, BSI will officially cease being a notified body in the UK on December 31, 2020.)

“The bar has been raised. There’s no doubt about it. The regulatory requirements under the MDR are higher than they were under the Medical Device Directive,” Slack told Medical Design & Outsourcing in an interview. “There is a requirement to upskill and increase the competence.”

The notified body fallout has left some medtech companies scrambling to find different ones. And the pandemic has put pressure on all sides as they try to complete their work toward MDR: Virtual audits have replaced in-person ones; many workers are working from home; and some have been unable to work.

And then there was a pandemic

The effects of the COVID-19 pandemic convinced the European Parliament to vote in April 2020 to postpone the original EU MDR deadline by one year. But the parliament held fast to the May 26, 2025, final transition date to the new system.

Some companies were counting on the delay that came in April and had eased up on MDR preparations, while others kept plugging away, according to Slack. Major companies are more likely to be ready for the new deadline, he added.

“I think the cadence of their product submissions is pretty well-established for most of the larger companies. We do an awful lot with the top 100 companies,” Slack said. “I think many of them have already set out their cadence over the next 2 or 3 years…

“The fact is that the MDR is a challenge,” he added. “We are very supportive of the MDR, but it’s a significant amount of work. There are not-insignificant costs to go through it.”

Facing the challenge

Most of the larger companies have been evaluating which of their MDD-certified devices are worth seeking MDR certification for in terms of inventory, sales and profits. Some have shared that the cost of compliance, including expansion of regulatory teams, has reached “several hundred million dollars,” Slack said.

“What we have seen is most of the bigger companies are having a big inventory rationalization,” he added. “Some of the big clients have tens of thousands of SKUs, so it’s a good opportunity to reduce it.”

For medtech companies themselves, the transition to EU MDR will result in potential changes to regulatory documents, processes, lifecycle requirements and labelling, according to Johnson & Johnson spokesperson Mindy Tinsley, who outlined the major steps companies have to take:
• Bring quality management systems into compliance and have them audited by an EU MDR-certified notified body.
• Parallel to that, assess and update the technical documentation supporting each product and, depending on the product’s class, have it assessed by a notified body.
• Ensure continuity in the supply chain, which will be affected by labelling requirements and the need for implant cards — device information cards that companies must supply to patients who have been implanted with their devices or systems.

Overall, Tinsley said, EU MDR touches every step in the product lifecycle.

A long process

Smith+Nephew started working toward MDR compliance in 2017, shortly after EU officials announced the regulatory upgrade, according to Melissa Guerdan, chief quality and regulatory affairs officer. The London-based company formed a large cross-functional team comprised of regulatory, R&D, commercial, quality and manufacturing employees to move its CE-Marked devices toward compliance with the new requirements. The company has also tasked operations team members with supply-chain planning in terms of new labels that MDR-certified products will need. The process has been “truly, truly touching almost all areas of our company,” Guerdan said in an interview with MDO.

“While there has been a contraction of the available resource of notified bodies, we have seen continuing positive interactions with each of our notified bodies (that) have seen resource constraints,” she added. “And so, our approach has been to be very proactive with them and helping them understand our plan for submissions so that they can plan their work a little better as well.”

One of the key MDR requirements is having sufficient clinical evidence for maintaining a particular product under the new regulation, according to Manoja Ranawake, VP of regulatory affairs for EMEA for Becton Dickinson (BD).

“There are a number of reasons for potentially phasing out a product, including the introduction of enhanced/new technology or low market demand for a product,” Ranawake added in an email to MDO. “Any decision to invest in a clinical trial or other means to obtain more robust clinical evidence has to be considered against all of the above-mentioned reasons.”

BD had nearly completed its compliance work when the European Parliament announced the MDR postponement, but that doesn’t mean the process was easy. New Jersey–based BD is a very large company that has three segments and nine business units, and its notified bodies are headquartered in the EU.

To ensure consistency across the organization, BD established an EU-based “center of excellence” to implement MDR, Ranawake explained. Its EU and U.S. teams regularly engage with notified bodies to ensure their understanding of the new regulation is in sync.

Working together

BD also works with AdvaMed, MedTech Europe other trade associations and their members to “help ensure an aligned approach for industry,” Ranawake said. “Based on these efforts, we develop internal guidance and policy documents, which help the business to implement the changes required under MDR and to remain compliant on an ongoing basis.”

One of the biggest challenges has been a lack of guidance documents available to industry, according to Brandi Panteleon, director of regulatory affairs and quality assurance for Medline Europe.

“Under the MDD, we had the MEDDEV guidance document. However, these documents have not been updated to cover the MDR requirements,” Panteleon told MDO in an email. “To overcome the lack of guidance documents, our regulatory team participates with Medtech Europe to gain knowledge from industry. They have been an engaged and helpful resource for us. Unfortunately, the training courses that were originally planned by other constancy groups have been cancelled due to COVID-19.”

Aside from the lack of guidance, Medline has carried out a fairly simple decision-making process when it comes to seeking MDR certification for approved devices.

“We estimated how much it would cost to update each file for MDR compliance and then compared it to both current and anticipated business,” Panteleon said. “We took the opportunity to evaluate our product portfolio carefully to assure that we would only spend valuable time and resources updating technical files to meet the MDR regulations if doing so made good business sense.”

J&J’s Tinsley added that it will take years to accomplish all the changes.

“Because we have a wide portfolio of medical devices, Johnson & Johnson Medical Devices will have both MDD-compliant and MDR-compliant devices on the market during the transition period,” Tinsley said. “This transition phase and the additional transition provisions, like continued validity of MDD CE certificates during the transition period, will help minimize disruption and ensure a smooth transition while allowing patients to have access to the medical technologies they need.”